Predictive performance of population pharmacokinetic models of imatinib in chronic myeloid leukemia patients.

Autor: Dilli Batcha JS; Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, India.; Center for Pharmacometrics, Manipal Academy of Higher Education, Manipal, India., Gota V; Department of Clinical Pharmacology, ACTREC, Tata Memorial Centre, Mumbai, India., Matcha S; Titus Family Department of Clinical Pharmacy, Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, University of Southern California, Los Angeles, USA., Raju AP; Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, India.; Center for Pharmacometrics, Manipal Academy of Higher Education, Manipal, India., Rao M; Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, India., Udupa KS; Department of Medical Oncology, Manipal Academy of Higher Education, Kasturba Medical College, Manipal, India., Mallayasamy S; Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, India. msv.rajan@manipal.edu.; Center for Pharmacometrics, Manipal Academy of Higher Education, Manipal, India. msv.rajan@manipal.edu.
Jazyk: angličtina
Zdroj: Cancer chemotherapy and pharmacology [Cancer Chemother Pharmacol] 2024 Jul; Vol. 94 (1), pp. 35-44. Date of Electronic Publication: 2024 Mar 05.
DOI: 10.1007/s00280-024-04644-w
Abstrakt: Background and Aim: Chronic myeloid leukemia is a myeloproliferative neoplasm associated with the specific chromosomal translocation known as the Philadelphia chromosome. Imatinib is a potent BCR-ABL tyrosine kinase inhibitor, which is approved as the first line therapy for CML patients. There are various population pharmacokinetic studies available in the literature for this population. However, their use in other populations outside of their cohort for the model development has not been evaluated. This study was aimed to perform the predictive performance of the published population pharmacokinetic models for imatinib in CML population and propose a dosing nomogram.
Methods: A systematic review was conducted through PubMed, and WoS databases to identify PopPK models. Clinical data collected in adult CML patients treated with imatinib was used for evaluation of these models. Various prediction-based metrics were used for assessing the bias and precision of PopPK models using individual predictions.
Results: Eight imatinib PopPK model were selected for evaluating the model performance. A total of 145 plasma imatinib samples were collected from 43 adult patients diagnosed with CML and treated with imatinib. The PopPK model reported by Menon et al. had better performance than all other PopPK models.
Conclusion: Menon et al. model was able to predict well for our clinical data where it had the relative mean prediction error percentage ≤ 20%, relative median absolute prediction error ≤ 30% and relative root mean square error close to zero. Based on this final model, we proposed a dosing nomogram for various weight groups, which could potentially help to maintain the trough concentrations in the therapeutic range.
(© 2024. The Author(s).)
Databáze: MEDLINE